Data science and technology will shape and redefine human drug research over the next few decades according to experts, who suggest a three-phase registration model for trials will evolve.
The ideas come from a workshop at the 18th Annual Conference of the Pharmaceutical Contract Management Group in Krakow, Poland where 200 delegates predicted what the clinical trial landscape would look like in 2050.
According to the authors “The consensus was that, by 2050, if you are working in clinical trials, you will be a data scientist. We can expect to see an increasing role of new technologies and a new three-phase registration model for novel therapies.”
For example, the authors predict that, thanks to advances in technology, future studies designed to assess product safety will follow adaptive principles.
“The first phase will involve an aspect of quality evaluation and biological proof-of-concept probably involving more preclinical modelling and engineered human cell lines and fewer animal studies.”
At the clinical stage, technology will also play a role according to the authors who predict that patients will be more involved in this phase of research.
“Once registered, new products will enter a period of adaptive clinical development intended to establish safety. This phase will most likely take around one-to-two years and explore tailored options for administration. Investigations will most likely be conducted in patients, possibly in a ‘patient-in-a-box’ setting.”
The authors also expect efficacy assessment to evolve, with patients and payors playing a greater role.
“On completion of safety licencing, drugs will begin an assessment of efficacy in partnership with those responsible for reimbursement – testing will be performed in patients, possibly where individual
patient involvement in safety testing will offer some reimbursement deal for future treatment.
They added that “Change is coming, though its precise form will likely depend on the creativity and vision of sponsors, regulators and payers.”
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